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Evidence-Based Medicine
(Bringing research evidence into practice)

Evidence-based Medicine
Opinion-based medicine
Experience-based medicine
Power-based medicine
Hope-based medicine
Logic-based medicine
Erratic-based medicine
Obat berbasis Opini
Obat berbasis pengalaman
Obat berbasis-Power
Kedokteran berbasis Harapan
Obat berbasis logika
Obat menentu berbasis


Medicine-based evidence
Pragmatic research
Outcome research
Evidence-based Medicine
Related with morbidity, mortality, & quality of life

Morbidity
Mortality
QoL
Patient
Satisfaction
Health
Status
Value
=
Quality
Cost

Diagnosis
Patient with complaint
History
Physical
Simple test
Specific test
Yes or no answer
Predictive value is the most important
The spectrum of the presentations must resemble
that in practice


Treatment
Patient with certain diagnosis
Does drug X more effective than Y?
Focus on the outcome, rather than its
explanation (biomolecular markers)
Yes or no outcome most useful

Prognosis
Usually in cohort studies
To inform the patient about the fate of the
patient
Absolute risk is more important than relative
risk
Absolute: Your risk of having second stroke in 1 year is 30%
Relative: Your risk of having second stroke in 1 year is 2 times
than in non-smokers (RR = 2)


EBM
Started in early 90s by clinical epidemiologists
1992 : only few articles on EBM
2000 : >1000 articles
Indonesia : started in 1997
Workshops : Yogya (2000)
IKA FKUI (2000, 2001, etc)
Group discussion on EBM / mailing list:
<ebm-f2000@yahoogroups.com>


EBM & Clinical Epidemiology
Fletcher & Fletcher: CE = The application of
epidemiologic principles in problems
encountered in clinical medicine
Sackett et al: CE = The basic science for clinical
medicine
Much resistance by experts
EBM: In principle no one disagree
All major medical journals have adopted EBM
Centers for EBM all over the world

Previous Practice
6 yrs medical
education
40-50 yrs
medical practice
Problems with patients:
Dx, Rx, Px
Consultants, colleagues
Textbooks
Handbooks
Lecture notes
Clinical guidelines
CME, seminars, etc
Journals
Usu. see only Results section,
or even worse, Abstract section

Previous Practice
Trust me
In my experience .
Logically
Textbook, handbook, capita selecta

The results.
Opinion-based medicine
Steroid inj. in prematures to prevent RDS
Routine episiotomy
Routine circumcision
Antibitotics for flu-like syndrome
Use of immunomodulators
Skin test before antibiotic injection
Routine chest X-ray for pre-op preparation
CT scan after minor head trauma
etc







What is
Evidence-based Medicine?


The conscientious, explicit, and judicious use of
current best evidence in making decisions about
the care of individual patients
Pemanfaatan bukti mutakhir yang sahih dalam
tata laksana pasien
Integration of (1) physicians competence
(2) valid evidence from studies
(3) patients preference

Pros : New paradigm in medicine
Extraordinary innovations,
only 2nd to Human Genome Project
Cons : New version of an old song
Fair : Nothing wrong with EBM, but:
Be careful in searching evidence
Meta-analyses, clinical trials, and all study
results should be critically appraised
Keyword for EBM:
Methodological skill to judge the validity of study
reports (Re. Andersen B: Methodo-logical errors in
medical research, 1989)

Years after graduation
Relative
% of
remaining
knowledge

2 4 6 8 10 12
$
100%
THE SLIPPERY SLOPE

WHY EBM?

1. Information overload
2. Keeping current with literature
3. Our clinical performance deteriorates with time
(the slippery slope)
4. Traditional CME does not improve clinical
performance
5. EBM encourages self directed learning process
which should overcome the above shortages


Our textbooks are
out-of-date
Fail to recommend Rx up to ten years after
its been shown to be efficacious.
Continue to recommend therapy up to ten
years after its been shown to be useless.

The Inevitable Consequence

On average, the clinically-important
knowledge of physicians deteriorates
rapidly after we complete our training.


Steps in EBM practice

1. Formulate clinical problems in answerable questions
2. Search the best evidence: use internet or other on-
line database for current evidence
3. Critically appraise the evidence for
Validity (was the study valid?)
Importance (were the results clinically
important?)
Applicability (could we apply to our patient?)
4. Apply the evidence to patient
5. Evaluate our performance
VIA

Main Area
Diagnosis
(Determination of disease or problem)

Treatment
(Intervention necessary to help the patient)

Prognosis
(Prediction of the outcome of the disease)


A 2-year old boy diagnosed presented with 6-
day high fever, conjunctival injection without
secretion, skin rash> blood test shows
leukocytosis, high ESR, CRP +++. He was
suspected to have Kawasaki disease. The
pediatrician is aware of the use of
immunoglobulin to prevent coronary
involvement, but uncertain about the dosage.

Medical students:
(Background question)
What is Kawasaki disease?
What is the etiology?
How it is diagnosed?
What is the treatment of choice?
Complications?

House Officers
(Foreground Question)

In a child with KD, would immuno -
globulin treatment, compared with no
immunoglobulin, reduce the chance to
develop coronary complication?

Foreground
questions
Background
questions
Experience with condition

Other Examples
In women with history of eclampsia, would
administration of low-dose aspirin during pregnancy
prevent eclampsia? (Prevention)

In young women with solitary thyroid nodule, can
USG, compared with biopsy, differentiate between
benign from malignant? (Diagnosis)
In women systemic lupus erythematosus, is history
of congestive heart failure, compared with no heart
failure, worsen the prognosis? (Prognosis)

1
Four elements of good clinical question: P I
C O
The Patient or Problem
The Intervention / Index
Comparative intervention (if relevant)
The Outcome

Four elements of a well constructed clinical
question: PICO
P I C O
The main
intervention
considered
The
alternative
to compare
with the
intervention
Outcome
expected
from this
intervention?
Description
of patient
or problem
B e b r i e f a n d s p e c i f i c

Relevance: Type of Evidence
POE: Patient-oriented evidence
mortality, morbidity, quality of life
DOE: Disease-oriented evidence
pathophysiology, pharmacology,
etiology

POEM
Patient-Oriented
Evidence
Morbity, Mortality
E
Comparing DOES and POEMs

Example


DOE


POEM


Comment

Antiarrhythmic
Therapy
Prostate
screening
PSA screening
detects prostate
Ca. early
? whether PSA
screening
mortality
Antihypertens.
Therapy
Drug A PVC
On ECG
Drug X BP

Drug X
mortality
Drug A >
mortality
DOE & POEM
contradicts
POEM agrees
With DOE


3
Appraising the evidence:
VIA

VIA
Validity: In Methods section:
design, sample, sample size, eligibility criteria
(inclusion, exclusion), sampling method,
randomization method, intervention,
measurements, methods of analysis, etc
Importance: In Results section
characteristics of subjects, drop out, analysis,
p value, confidence intervals, etc
Applicability: In Discussion section + our patients
characteristics, local setting

Example:
Critical appraisal for therapy
Were the subjects randomized?
Were all subjects received similar treatment?
Were all relevant outcomes considered?
Were all subjects randomized included in the
analysis?
Calculate CER, EER, RRR, ARR, and NNT
Were study subjects similar to our patients in
terms of prognostic factors?


Hierarchy of evidence
Weight of
Scientific
Scrutiny
Meta-analysis of RCT

Large RCT

Small RCT

Non-Randomized trials

Observational studies

Case series / reports

Anecdotes, expert, consensus
Level 1
Level 2
Level 3
Level 4
A
B
C
Rec

Implementation of EBM practice:
How to get started
1. Teaching EBM in medical schools / PPDS
Easier than to change the already existing attitude
Most important
May be included in formal curricula or integrated in
existing activities: ward rounds, on calls, case
presentations, group discussions, journal clubs, etc
2. Workshop for teaching staff
3. Workshop for practitioners, incl. nurses


Resistance to EBM teaching & learning
Rudimentary skill in critical appraisal /
methodological skill
Limited resources, esp. time factor
Lack of high quality evidence
Skepticism toward evidence-based practice
Happy with current practice

Patients
values
Physicians
competence
Valid
evidence

Formulate
In answerable
question
Search the
evidence
Critically
Appraise
The evidence
Apply
The evidence
Patient
With problem

Criticism to EBM
EBM makes expensive medical care
EBM cannot be implemented in developing
countries
EBM is costly and time consuming
EBM ignore pathophysiology & reasoning
EBM ignore experience and clinical judgment
EB-guidelines etc interfere with professional
autonomy

Criticism to EBM
EBM makes expensive medical care
Cf:
Routine antibiotics for ARTI & diarrhea
Liberal indication for C-section
Unnecessary sophisticated procedures /
exams
Unnecessary / harmful treatment:
steroid for recurrent cough

Criticism to EBM
EBM cannot be implemented in developing countries
By definition EBM is implemented if it is
implementable (patients preference and local
condition) for the benefit of the patients and
the community

Criticism to EBM
EBM is costly and time consuming
EBM does requires facilities at the cost of
quality medical care!
Cost benefit ratio should be assessed in
individual and community levels

Criticism to EBM
EBM ignores pathophysiology & reasoning
EBM encourages clinical reasoning in the light
of valid and important evidence
Pathophysiology and reasoning should be
seen as hypothesis and should end-up in
empirical evidence

Criticism to EBM
EBM ignore experience and clinical judgment
Personal experience and clinical judgment are
by no means can be eliminated
EBM encourage detailed and systematic
documentation of experience and judgment
Subjective experience should be, whenever
possible, translated into more objective
measures

Criticism to EBM
EB-guidelines interfere with professional autonomy
Professional conduct (competence, altruism,
openness, collegiality, ethics) is encouraged in EBM
Every physician should develop their own practice
attitude based on his/her profess-ionalism, valid
evidence, and patients values
Development of clinical guidelines and other
standards of care should be seen as a guide and
implemented according to clinical setting

Advantages of EBM
Encourages reading habit
Improves methodological skill (and willingness
to do research?!)
Encourages rational & up to date management
of patients
Reduces intuition & judgment in clinical
practice, but not eliminates them
Consistent with ethical and medico-legal aspects
of patient management



End Result


Self directed, life-long learning attitude
for high quality patient care


Conclusion
EBM is nothing more than a

framework of systematic use of

current valid study results

relevant to our patient